Bone fixation assembly, implants and methods of use

ABSTRACT

Bone fusion system, plate system, guide, implant, kit and methods for using the bone fusion system, plate system, guide and implant are disclosed. The bone fusion system includes an alignment guide, an implant, and at least one fastener inserted through the implant. The alignment guide includes a body portion, a first lobe positioned at a first end of the body portion, a second lobe positioned at a second end of the body portion, and an extension member extending away from a first side of the body portion. The implant includes a body portion, a first arm extending away from the body portion in a first direction, a second arm extending away from the body portion in a second direction, and a third arm extending away from the body portion laterally between the first and second arms. Finally, methods for using the bone fusion system, plate system, guide and implant are disclosed.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of PCT Application No.PCT/US2017/065315 filed on Dec. 8, 2017, which is incorporated herein byreference in its entirety.

FIELD OF INVENTION

The present disclosure relates generally to general surgery andorthopedic implants used for achieving bone fusion. More specifically,but not exclusively, the present disclosure relates to surgical devicesfor fixation of human bones, such as, the foot bones, and to theinternal fixation of the proximal portion of metatarsal bones to thebones of the mid-foot and rear-foot to stabilize the realignment of afracture, dislocation, fusion or the like of the tarso-metatarsaljoints, mid-foot and rearfoot.

BACKGROUND OF THE INVENTION

The proximal metatarsal base at its articulation with the mid-tarsus ofthe human foot is a common site of fracture and/or dislocationespecially in persons with neuropathy (neuropathic arthropathy orCharcot joints). The metatarsals at the mid-tarsal articulation displacedorsally and lead to progressive deformity and instability of the foot.Ultimately this can progress to a deformity that leads to excessive softtissue pressures of the plantar foot and wound development. This type ofwound is difficult to heal due to the forces in this area from weightbearing. Instability and deformity of the mid-foot can lead toinfection-prone wounds that often result in amputation. Realignment andstabilization of the joints can provide a more anatomic alignment to thefoot, provide stability, and dramatically decrease wound and associatedamputation risk.

Stable fixation of the metatarsus, mid-tarsus and tarsus can bechallenging with currently available devices. A variety of bone screwsserving as “beams” have been used in attempt to provide fixation ofthese foot bone segments. They are most effective at providing stabilityto the bones of the tarsus and mid-tarsus. The smaller metatarsal bonesare particularly difficult to include in “beam” screw fixation. Thefirst metatarsal bone can be fixated by an axial “beam” screw due to itssize and alignment with respect to the mid-tarsus and tarsus, however,the smaller metatarsals do not lend themselves to this type of fixation.Alternatively, dorsal plates and screws are used to maintain realignmentof the metatarsal bases to the mid-tarsus. Currently available bonefixation plates in this area do not span the metatarsal, mid-tarsal, andtarsal foot segments well without excessive bulk and soft tissuedisruption.

The challenge for “beam” screw fixation of the smaller metatarsals isthe size of the beam screw needed to prevent screw failure as comparedthe size of the metatarsal being fixated. Significant violation of themetatarsal base would occur with insertion of a large screw from theproximal metatarsal extending through the mid-tarsus and ending in thetarsus. An ideal “beam” screw construct for stabilization of a relocatedmetatarsal to mid-tarsal to tarsal foot bone segments would includemultiple large diameter screws spanning all three of these bonesegments. “Beam” screw fixation inclusive of metatarsal bases 2-5 issuboptimal with current device options.

Accordingly, it is an object of the present disclosure to overcome oneor more of the above-described drawbacks and/or disadvantages of thecurrently used procedures. For example, in view of the deficiencies ofthe currently available implants and methods of fixing the proximalportion of metatarsal bones (base) to the bones of the mid-foot andrear-foot to stabilize realignment of a fracture, dislocation, fusion orthe like of the tarso-metatarsal joints, mid-foot and rear-foot thatovercomes the deficiencies of the prior art, it would be desirable todevelop devices, systems, instrumentation, and methods for maintaining,correcting and/or fusing joint deformities to overcome the above-noteddrawbacks of the currently available implant and surgical solutions.

SUMMARY OF THE INVENTION

Aspects of the present disclosure provide bone fixation devices for usein a method of fusing bones. Specifically, the present disclosurerelates to surgical devices and methods for fixation of human bones,such as, the foot bones, and to the internal fixation of the proximalportion of metatarsal bones to the bones of the mid-foot and rear-footto stabilize realignment of a fracture, dislocation, fusion or the likeof the tarso-metatarsal joints, mid-foot and rear-foot.

In one aspect, provided herein is a bone fusion system, including analignment guide, an implant, and at least one fastener inserted throughthe implant.

In another aspect, provided herein is an alignment guide, including abody portion, a first lobe positioned at a first end of the bodyportion, a second lobe positioned at a second end of the body portion,and an extension member extending away from a first side of the bodyportion.

In yet another aspect, provided herein is an implant, including a bodyportion, a first arm extending away from the body portion in a firstdirection, a second arm extending away from the body portion in a seconddirection, and a third arm extending away from the body portionlaterally at a position between the first arm and the second arm.

In a further aspect, provided herein is a method for using a fusionsystem, including preparing at least one joint and inserting temporaryfixation k-wires across the at least one joint. The method may alsoinclude obtaining an alignment guide and positioning the alignment guideon a foot over the at least one joint. In addition, the method mayinclude reaming a recess into the at least one joint and positioning animplant on the foot. The implant, includes a body portion, a first armextending away from the body portion in a first direction, a second armextending away from the body portion in a second direction, a third armextending away from the body portion laterally at a position between thefirst arm and the second arm, and an extension member extending awayfrom a bottom surface of the third arm. The extension member is insertedinto the recess in the at least one joint. The method further includesfixing the implant to the foot, removing the temporary fixation k-wires,and closing an incision.

These, and other objects, features and advantages of this disclosurewill become apparent from the following detailed description of thevarious aspects of the disclosure taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the detailed description herein, serve to explain theprinciples of the disclosure. The drawings are only for purposes ofillustrating preferred embodiments and are not to be construed aslimiting the disclosure. It is emphasized that, in accordance with thestandard practice in the industry, various features are not drawn toscale. In fact, the dimensions of the various features may bearbitrarily increased or reduced for clarity of discussion. Theforegoing and other objects, features and advantages of the disclosureare apparent from the following detailed description taken inconjunction with the accompanying drawings in which:

FIG. 1 is a second end, top perspective view of an alignment guide, inaccordance with an aspect of the present disclosure;

FIG. 2 is a first end, top perspective view of the alignment guide ofFIG. 1, in accordance with an aspect of the present disclosure;

FIG. 3 is a first end, bottom perspective view of the alignment guide ofFIG. 1, in accordance with an aspect of the present disclosure;

FIG. 4 is a second end, bottom perspective view of the alignment guideof FIG. 1, in accordance with an aspect of the present disclosure;

FIG. 5 is a top view of the alignment guide of FIG. 1, in accordancewith an aspect of the present disclosure;

FIG. 6 is a bottom view of the alignment guide of FIG. 1, in accordancewith an aspect of the present disclosure;

FIG. 7 is a first end elevational view of the alignment guide of FIG. 1,in accordance with an aspect of the present disclosure;

FIG. 8 is a second end elevational view of the alignment guide of FIG.1, in accordance with an aspect of the present disclosure;

FIG. 9 is a first side elevational view of the alignment guide of FIG.1, in accordance with an aspect of the present disclosure;

FIG. 10 is a second side elevational view of the alignment guide of FIG.1, in accordance with an aspect of the present disclosure;

FIG. 11 is a top perspective view of an implant, in accordance with anaspect of the present disclosure;

FIG. 12 is a bottom perspective view of the implant of FIG. 11, inaccordance with an aspect of the present disclosure;

FIG. 13 is a top view of the implant of FIG. 11, in accordance with anaspect of the present disclosure;

FIG. 14 is a bottom view of the implant of FIG. 11, in accordance withan aspect of the present disclosure;

FIG. 15 is a first end elevational view of the implant of FIG. 11, inaccordance with an aspect of the present disclosure;

FIG. 16 is a second end elevational view of the implant of FIG. 11, inaccordance with an aspect of the present disclosure;

FIG. 17 is a first side elevational view of the implant of FIG. 11, inaccordance with an aspect of the present disclosure;

FIG. 18 is a second side elevational view of the implant of FIG. 11, inaccordance with an aspect of the present disclosure;

FIG. 19 is a top perspective view of a plate system, in accordance withan aspect of the present disclosure;

FIG. 20 is a top perspective view of a foot with temporary fixationmembers positioned within the target bones, in accordance with an aspectof the present disclosure;

FIG. 21 is a top perspective view of the foot of FIG. 20 with thealignment guide of FIG. 1 positioned on the foot, in accordance with anaspect of the present disclosure;

FIG. 22 is a side perspective view of FIG. 21, in accordance with anaspect of the present disclosure;

FIG. 23 is a top perspective view of the foot and alignment guide ofFIG. 21 with a joint preparation paddle inserted into the alignmentguide, in accordance with an aspect of the present disclosure;

FIG. 24 is a side perspective view of the foot of FIG. 23 with fixationwires inserted through the alignment guide and into the foot, inaccordance with an aspect of the present disclosure;

FIG. 25 is a top perspective view of the foot of FIG. 24, in accordancewith an aspect of the present disclosure;

FIG. 26 is a top perspective view of the foot of FIG. 25 after removalof the joint preparation paddle, in accordance with an aspect of thepresent disclosure;

FIG. 27 is a side perspective view of the foot of FIG. 26 with a reamerinserted through the alignment guide and into the foot, in accordancewith an aspect of the present disclosure;

FIG. 28 is an top perspective view of the foot of FIG. 27 after theremoval of the reamer, two of the fixation wires, and the alignmentguide, showing the reamed portion of the bones, in accordance with anaspect of the present disclosure;

FIG. 29 is a side perspective view of the foot of FIG. 28 afterinsertion of the implant of FIG. 11, in accordance with an aspect of thepresent disclosure;

FIG. 30 is a top perspective view of the foot of FIG. 29, in accordancewith an aspect of the present disclosure;

FIG. 31 is a top perspective view of the foot of FIG. 30 after an olivewire is inserted into the foot through the implant, a drill guide iscoupled to the implant, and a drill is inserted through the drill guideinto the foot, in accordance with an aspect of the present disclosure;

FIG. 32 is a side perspective view of the foot of FIG. 31 afterinsertion of two bone fasteners through the implant and into the foot,in accordance with an aspect of the present disclosure;

FIG. 33 is a side perspective view of the foot of FIG. 32 after couplinga k-wire guide to the implant and inserting a k-wire through the k-wireguide and into the foot, in accordance with an aspect of the presentdisclosure;

FIG. 34 is a side perspective view of the foot of FIG. 33 after removalof the k-wire guide and insertion of a depth gauge over the k-wire, inaccordance with an aspect of the present disclosure;

FIG. 35 is a top perspective view of the foot of FIG. 34 after removalof the depth gauge and insertion of a soft tissue protector over thek-wire and a drill bit inserted through the tissue protector and overthe k-wire, in accordance with an aspect of the present disclosure;

FIG. 36 is a side perspective view of the foot of FIG. 35 after removalof the drill, tissue protector and k-wire and insertion of a beamfastener, in accordance with an aspect of the present disclosure;

FIG. 37 is a side perspective view of the foot of FIG. 36 afterinsertion of two additional bone fasteners through the implant and intothe foot, in accordance with an aspect of the present disclosure; and

FIG. 38 is a perspective view of a fusion system with the template ofFIG. 1, the plate system of FIG. 19, a joint preparation paddle, areamer, a wire, a drill bit, a cannulated depth gauge and a soft tissueprotector, in accordance with an aspect of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

Generally stated, disclosed herein are embodiments of plate templates orreaming guides, implant or plate, and plate system or bone fixationdevices. Further, surgical methods for using the devices for fixation ofhuman bones, such as, the foot bones, and to the internal fixation ofthe proximal portion of metatarsal bones to the bones of the mid-footand rear-foot to stabilize realignment of a fracture, dislocation,fusion or the like of the tarso-metatarsal joints, mid-foot andrear-foot are discussed.

In this detailed description and the following claims, the wordsproximal, distal, anterior or plantar, posterior or dorsal, medial,lateral, superior and inferior are defined by their standard usage forindicating a particular part of a bone or implant according to therelative disposition of the natural bone or directional terms ofreference. For example, “proximal” means the portion of a device orimplant nearest the torso, while “distal” indicates the portion of thedevice or implant farthest from the torso. As for directional terms,“anterior” is a direction towards the front side of the body,“posterior” means a direction towards the back side of the body,“medial” means towards the midline of the body, “lateral” is a directiontowards the sides or away from the midline of the body, “superior” meansa direction above and “inferior” means a direction below another objector structure. Further, specifically in regards to the foot, the term“dorsal” refers to the top of the foot and the term “plantar” refers thebottom of the foot.

Similarly, positions or directions may be used herein with reference toanatomical structures or surfaces. For example, as the current devicesand methods are described herein with reference to use with the bones ofthe foot, the bones of the foot, ankle and lower leg may be used todescribe the surfaces, positions, directions or orientations of thedevices, instrumentation and methods. Further, the devices and methods,and the aspects, components, features and the like thereof, disclosedherein are described with respect to one side of the body for brevitypurposes. However, as the human body is relatively symmetrical ormirrored about a line of symmetry (midline), it is hereby expresslycontemplated that the devices and methods, and the aspects, components,features and the like thereof, described and/or illustrated herein maybe changed, varied, modified, reconfigured or otherwise altered for useor association with another side of the body for a same or similarpurpose without departing from the spirit and scope of the disclosure.For example, the devices and methods, and the aspects, components,features and the like thereof, described herein with respect to theright foot may be mirrored so that they likewise function with the leftfoot. Further, the devices and methods, and the aspects, components,features and the like thereof, disclosed herein are described withrespect to the foot for brevity purposes, but it should be understoodthat the devices and methods may be used with other bones of the bodyhaving similar structures, for example the upper extremity, and morespecifically, with the bones of the wrist, hand, and arm.

Referring to the drawings, wherein like reference numerals are used toindicate like or analogous components throughout the several views, andwith particular reference to FIGS. 1-10, there is illustrated a platetemplate, alignment guide, reaming guide 100. The plate template 100 mayinclude a top or dorsal surface 102 opposite a bottom or plantar surface104, a first or proximal end 106 opposite a second or distal end 108,and a first or medial side 110 opposite a second or lateral side 112.The template 100 may be, for example, curved, curvilinear or otherwisearced between the first end 106 and the second end 108. The template 100may be, for example, further curved, curvilinear or otherwise arcedbetween the first side 110 and the second side 112. The template 100 maybe, for example, curved, curvilinear or otherwise arced to match theshape of the bone that the plantar surface 104 of the template 100 willengage.

The plate template 100 may also include a body portion 114 may have afirst or medial side 110 and a second or lateral side 115. The bodyportion 114 may include a first lobe 116, a second lobe 118 and anextension member 120, as shown in FIGS. 1-6. The first lobe 116 mayextend, for example, to the proximal end 106 of the template 100. Thesecond lobe 118 may extend, for example, to the distal end 108 of thetemplate 100. The first lobe 116 may have, for example, a length longerthan a length of the second lobe 118. The extension member or lateralextension member 120 may extend, for example, from the lateral side 115of the body member 114 to the lateral side 112 of the plate template100. The extension member 120 may include a third lobe 122 positioned atthe lateral side 112 and a tab 124 positioned between the third lobe 122and the lateral side 115 of the body portion 114. The first side of theextension member 120 on the proximal end 106 may be, for example,slightly angled from the lateral side 115 of the body portion 114 to theoutermost point of the extension member 120 on the lateral side 112 ofthe template 100 forming a first angle. The second side of the extensionmember 120 proximate to the distal end 108 may also be, for example,angled from the lateral side 115 of the body portion 114 at a positionnear the distal end 108 to the outermost point on the lateral side 112of the template 100 forming a second angle. The first and second anglesmay be, for example, measured from the lateral side 115 of the bodyportion 114 and the second angle may be larger than the first angle. Theextension member 120 may also have, for example, a length measuredbetween the lateral side 115 of the body portion 114 and the lateralside 112 of the template 100. The length of the extension member 120 maybe, for example, longer than the length of the second lobe 118 andshorter than the length of the first lobe 116.

With continued reference to FIGS. 1-6, the template 100 also includes aplurality of through holes 126, 128, 130. The through holes 126, 128,130 may be, for example, sized and shaped or configured to receive awire, for example, a k-wire, guide wire, olive wire, or the like, tosecure the template 100 to a patient's bones. As shown, the template 100may include, for example, a first through hole 126 positioned betweenthe first or proximal end 106 and a midpoint of the body portion 114 ofthe template 100. The template 100 may also include, for example, asecond through hole 128 positioned near the second or distal end 108 ofthe template 100. Further, the template 100 may include, for example, athird through hole 130 positioned in the third lobe 122 near the lateralside 112 of the template 100, near an end of the extension member 120.The through holes 126, 128, 130 may be, for example, straight or angledas they extend between the top surface 102 and the bottom surface 104 ofthe template 100.

As shown in FIGS. 1-10, the template 100 may further include a reamerguide 132 extending away from the top surface 102 of the template 100.The reamer guide 132 may be, for example, positioned on the extensionmember 120 between the body portion 114 and the third lobe 122. Thereamer guide 132 may also be positioned, for example, adjacent to thetab 124. A center of the reamer guide 132 may be positioned, forexample, a set distance from a proximal edge of the tab 124. Thedistance between the center of the reamer guide 132 and the proximaledge of the tab 124 may be, for example, approximately 0.5 cm to 3 cmand more specifically, approximately 1 cm. The reamer guide 132 mayhave, for example, a circular or round shape. The reamer guide 132 mayalso include a through hole or reamer hole 134. The reamer hole 134 mayextend from a top surface of the reamer guide 132 through the reamerguide 132 to a bottom surface 104 of the template 100. The reamer guide132 may be, for example, sized and shaped or configured to receive aseparate reamer instrument, as discussed in greater detail below withrespect to FIGS. 27 and 28.

Referring now to FIGS. 11-18, an implant or plate 200 is shown. Theimplant 200 includes a top or dorsal surface 202 opposite a bottom orplantar surface 204, a first or proximal end 206 opposite a second ordistal end 208, and a first or medial side 210 opposite a second orlateral side 212. The implant 200 may be, for example, curved,curvilinear or otherwise arced between the first end 206 and the secondend 208. The implant 200 may be, for example, further curved,curvilinear or otherwise arced between the first side 210 and the secondside 212. The implant 200 may be, for example, curved, curvilinear orotherwise arced to match the shape of the bone that the plantar surface204 of the implant 200 will engage.

The implant 200 may also include a body portion 214 with a first orproximal arm 216, a second or distal arm 222, and a third or lateral arm226. The first arm 216 may extend, for example, to the proximal end 206of the implant 200. The second arm 222 may extend, for example, to thedistal end 208 of the implant 200. The third arm 226 may extend, forexample, away from the body portion 214 to the lateral side 212. Asshown in FIGS. 13 and 14, the third arm 226 may be, for example, curvedor arced toward the proximal end 206 as the third arm 226 extends awayfrom the body portion 214. The implant 200 may also include an extensionmember or plantar extension member 230 extending away from the bottomsurface 204 of the third arm 226. The extension member 230 may bepositioned, for example, adjacent to the body portion 214 and alignedwith the distal edge of the third arm 226. The first arm 216 may be, forexample, longer than the second arm 222.

The first arm 216 may include, for example, at least one first fastenerhole 218 and a through hole or wire hole 220, as shown in FIGS. 11-14.The at least one first fastener hole 218 extends from the top surface202 through the bottom surface 204. As shown, the at least one firstfastener hole 218 may be, for example two fastener holes 218. Forexample, one first fastener hole 218 may be positioned at the first end206 and a second first fastener hole 218 may be positioned between theone first fastener hole 218 and a midpoint along the longitudinal axisof the implant 200. The fastener holes 218 may be, for example, sizedand shaped or configured to receive a bone fastener, bone screw, or thelike for coupling the implant 200 to the bones of a patient, asdescribed in greater detail below. The fastener holes 218 may be, forexample, threaded on an interior surface of the holes 218. The threadsof both holes 218 may include, for example, at least one scallop orcutout forming a break in the threads. The threads and at least onecutout may be configured or shaped to lock a fastener or screw (notshown) in the holes 218. The through hole 220 may be, for example,positioned between the one first fastener hole 218 and the second firstfastener hole 218. The through hole 220 may be, for example sized andshaped or configured to receive a wire, for example, a k-wire, guidewire, olive wire or the like for positioning the implant 200 onto apatient's foot, as described in greater detail below.

The second arm 222 may also include, for example, at least one secondfastener hole 224, as shown in FIGS. 11-14. The at least one secondfastener hole 224 extends from the top surface 202 through the bottomsurface 204. As shown, the at least one second fastener hole 224 may be,for example, one second fastener hole 224 positioned at the distal end208 of the implant 200. The one second fastener hole 224 may be, forexample, sized and shaped or configured to receive a bone fastener, bonescrew, or the like for coupling the implant 200 to the bones of apatient, as described in greater detail below. The one second fastenerhole 224 may be, for example, threaded on an interior surface of thehole 224. The threads may include, for example, at least one scallop orcutout forming a break in the threads. The threads and at least onecutout may be configured or shaped to lock a fastener or screw (notshown) in the hole 224.

With continued reference to FIGS. 11-14, the third arm 226 may alsoinclude at least one third fastener hole 228. The at least one thirdfastener hole 228 extends from the top surface 202 through the bottomsurface 204. As shown, the at least one third fastener hole 228 may be,for example, one third fastener hole 228 positioned at the end of thethird arm 226 on the lateral side 212 of the implant 200. The fastenerhole 228 may be, for example, sized and shaped or configured to receivea bone fastener, bone screw, or the like for coupling the implant 200 tothe bones of a patient, as described in greater detail below. Thefastener hole 228 may be, for example, threaded on an interior surfaceof the holes 228. The threads may include, for example, at least onescallop or cutout forming a break in the threads. The threads and atleast one cutout may be configured or shaped to lock a fastener or screw(not shown) in the hole 228.

Referring now to FIGS. 11, 12, 15 and 16, the extension member 230 mayinclude a hole or screw hole 232. The hole 232 may extend, for example,through the extension member 230 in a proximal-distal direction, asshown in FIGS. 11 and 12. The hole 232 may be positioned to extend, forexample, through the center of the extension member 230, althoughalternative positions for the hole 232 are also contemplated. The hole232 may be, for example, sized and shaped or configured to receive abone fastener, bone screw, beaming screw, pin, rod, or the like forcoupling the implant 200 to the bones of a patient, as described ingreater detail below. In one embodiment, the hole 232 may be, forexample, threaded on an interior surface of the hole 232. The threadsmay include, for example, at least one scallop or cutout (not shown)forming a break in the threads. The threads and at least one cutout maybe configured or shaped to lock a fastener or screw (not shown) in thehole 232. It is further understood that the interior surface of the hole232 may be smooth or threadless. As shown in FIGS. 17 and 18, theextension member 230 may be, for example, shaped to be recessed into apatient's bones and/or joint. The extension member 230 may include, forexample, a first side positioned facing the proximal end 206 of theimplant 200, which may be planar. The extension member 230 may alsoinclude, for example, a second side positioned facing the distal end 208of the implant 200 and the second side may be curved as it extends in adorsal-plantar direction. The second side of the extension member 230may also be, for example, curved in a medial-lateral direction. Thecurvature in the medial-lateral direction may, for example, match thecurvature of the plate 200 at the point where the body portion 214engages the third arm 226. As shown in FIG. 18, the extension member 230may, for example, taper from the bottom surface 204 of the implant 200in a dorsal-plantar direction. In addition, as shown in FIGS. 15 and 16,the extension member 230 may be tapered in medial-lateral direction asit extends away from the bottom surface 204 of the implant 200. Further,the peripheral outer surface of 230 extending between the first side andthe second side may be, for example, curved to facilitate insertion andavoid impingement.

A plate system or bone fixation device 250 is shown in FIG. 19. Theplate system 250 includes the implant 200, fasteners 252, 254, 256 and abeam fastener 258. Each component of the plate system 250 may be madefrom, for example, a biocompatible material, including but not limitedto a metal, polymer, composite, etc. With respect to the fasteners 252,254, 256, the terms “fastener,” “bone screw,” “fixator,” “bone screw,”and “screw” may be used interchangeably herein as they essentiallydescribe the same type of device. With respect to fastener 258, theterms “fastener,” “beam fastener,” “bone screw,” “beam screw,”“fixator,” “elongate member,” “rod,” and “screw” may be usedinterchangeably herein as they essentially describe the same type ofdevice. As shown in FIG. 19, the plate system 250 may include a onefirst fastener 252 inserted into the one first fastener hole 218, asecond first fastener 252 inserted into the second first fastener hole218, a second fastener 254 inserted into the second fastener hole 224,and a third fastener 256 inserted into the third fastener hole 228. Inaddition, the beam fastener 258 may be inserted through the hole 232 inthe extension member 230.

With continued reference to FIG. 19, the fasteners 252, 254, 256, 258may include a head portion and a shaft portion. The head portion mayinclude a superior end and an inferior end. The superior end of the headportion may have a tool engagement opening, as shown in FIG. 19. Thetool engagement opening may have a multi-lobed shape, although otherpolygonal shapes are also contemplated, including a hexagonal shape. Thefasteners 252, 254, 256, 258 may also have a cannulated opening (notshown) extending from the tool engagement opening through the entirelength of the fasteners 252, 254, 256, 258. The inferior end of the headportion may optionally be threaded to engage corresponding threads inthe holes 218, 224, 228, 232. The inferior end of the head portion iscoupled to an end of the shaft portion. The shaft portion may be, forexample, threaded along the entire length of the fasteners 252, 254,256, 258 or only along a portion. The fasteners 252, 254, 256, 258 maybe, for example, available in multiple sizes with threaded sections ofvarious lengths, including, for example, a fully threaded shaft portion.The length of the threaded section may correspond to the orientation ofinsertion into the patient's bones and the bones that the fastener 252,254, 256 is inserted through and into. The threaded section of the shaftportion may also include a tip. The tip may be, for example, blunt orinclude at least one cutting thread or be self-tapping thread to assistin insertion into the patient's bone.

As shown in FIG. 38, an implant kit or fusion system 280 may include atleast one plate template 100, at least one plate 200, a plurality offasteners 252, 254, 256, and at least one beam fastener 258. The fusionsystem may also include at least one joint preparation paddle 260, andat least one reamer 330. The fusion system may also include, a pluralityof wires 312, 314, 316, 324, 326, 328, 336, 344, at least one drillguide 338 s as shown in FIG. 31, at least one drill bit 340, 350, ak-wire guide 342 as shown in FIG. 33, a cannulated depth gauge 346, anda soft tissue protector 348. The plurality of wires 312, 314, 316, 324,326, 328, 336, 344 may be, for example, threaded or non-threaded wires,guide wires, k-wires, olive wires, or other temporary fixation membersas known by one of ordinary skill in the art. A sample wire 312, 314,316, 324, 326, 328, 336, 344 is shown in FIG. 28.

Referring now to FIGS. 20-37, one embodiment of a surgical method ofusing the plate template 100 and plate system 250 is shown. The methodmay include making an incision over the calcaneocuboid joint 320proximally and extending past the 4^(th)/5^(th) metatarsal-cuboid joints318. After the incision is made, additional soft tissue dissection maybe performed until the joints 318, 320 are accessible. Next, thecartilage may be removed from the 4^(th)/5^(th) metatarsal-cuboid joints318, as well as the calcaneocuboid joint 320 using the surgeon'spreferred technique. Once the joint preparation is complete, the jointsare realigned to achieve a plantigrade foot. As shown in FIG. 20, thetemporary fixation may then occur and may include inserting a firsttemporary fixator or k-wire 312 from the dorsal fifth metatarsal 306into the cuboid 308 proximally. Then, a second temporary fixator ork-wire 314 may be placed across the fifth metatarsal 306, fourthmetatarsal 304, and third metatarsal 302. Finally, a third temporaryfixator or k-wire 316 may be placed to stabilize the cuboid 308 to thecalcaneus 310. It is also contemplated that if necessary due to bonequality and/or surgeon preference, placement of the temporary fixators312, 314, 316 may be altered as would be understood by one of ordinaryskill in the art to achieve temporary fixation of the calcaneocuboidjoint 320 and 4^(th)/5^(th) metatarsal-cuboid joints 318. Referring nowto FIGS. 21-36, the wires 312, 314, 316 are not shown for ease ofviewing, however, the wires 312, 314, 316 are still inserted in the foot300 during the steps illustrated in these figures and removed during thetechnique once those particular bones and/or joints are stabilized.

Referring now to FIGS. 21 and 22, the method may include selecting thedesired size of the plate template 100 and positioning the template 100over the cuboid 308, fifth metatarsal 306 and fourth metatarsal 304.Specifically, the flat surface of the tab 124 on the proximal portion ofthe lateral extension member 120 is aligned with the 4^(th)/5^(th)metatarsal-cuboid joint 318. Then, the template 100 may be centeredgenerally over the fourth metatarsal 304 and fifth metatarsal 306 and,as shown in FIG. 23, a joint preparation paddle 260 may be placed intothe reamer hole 134 of the reamer guide 132 to contact the 4^(th)/5^(th)metatarsal-cuboid joint 318. The joint preparation paddle 260 includes ashaft 262, a head portion 264 extending away from a distal end of theshaft 262, and a joint extension member 266 extending away from thedistal end of the head portion 264, as shown in FIG. 24. The headportion 264 may be, for example, shaped to fit into the reamer hole 134of the template 100. The joint extension member 266 may be, for example,shaped to be inserted between two bones, such as, fourth and fifthmetatarsals 304, 306 to center the template 100 over the 4^(th)/5^(th)metatarsal joint. The tip of the joint extension member 266 may be sharpto transect the ligaments across a joint. The width and thickness of thetip of the joint extension member 266 may be minimized and selected, forexample, to provide minimal joint and ligament disruption when insertedbetween two bones. As the joint preparation paddle 260 is inserted intothe reamer hole 134, the surgeon aligns the joint extension member 266of the paddle 260 parallel to the metatarsals 304, 306 and pushes thepaddle 260 into the intermetatarsal joint 322 to center the template100, as shown in FIGS. 23 and 24. The template 100 and paddle 260 may beused to position the starting point of a screw, for example, 1 cm fromthe 4^(th)/5^(th) metatarsal-cuboid joint 318 and centered for reamingbetween the fourth and fifth metatarsals, 304, 306.

Referring now to FIGS. 24 and 25, the method may also include insertinga first wire 324, for example, a threaded k-wire, into the cuboid 308through the hole 126 in the proximal aspect or proximal end 106 of thetemplate 100. Next, a second wire 326, for example, a threaded olivewire, may be inserted into the fourth metatarsal 304 through the hole128 in the distal end 108 of the template 100. In addition, a third wire328, for example, a threaded olive wire, may be inserted into the fifthmetatarsal 306 through the hole 130 in the lateral extension member 120.Although non-threaded k-wires and olive wires are contemplated, threadedk-wires and olive wires are preferred to assist with preventing back-outof the template 100 while reaming the bones 304, 306.

After the wires 324, 326, 328 are inserted into the bones 308, 304, 306,respectively, the joint preparation paddle 260 may be removed from thetemplate 100, as shown in FIG. 26. Then, the placement of the template100 may be confirmed under fluoroscopy. If the template 100 is in thedesired position, a reamer 330 may be selected to correspond to the hole134 in the selected template 100. The reamer 330 may be attached to ahandle (not shown) and the reamer 330 may be inserted into the hole 134in the template 100 until the distal end of the reamer 330 contactsbone. The reamer 330 may include a plurality of solid and dashed lines332 positioned around the circumference of the head portion of thereamer 330, as shown in FIG. 27. Once the reamer 330 contacts the bones304, 306, the surgeon should note which solid or dashed line 332 isclosest to the top of the reamer guide 132. Next, the bones 304, 306 maybe reamed until the next solid or dashed line 332, respectively, of thereamer 330 to ensure adequate depth of the reamed hole 334, as shown inFIGS. 27 and 28. With continued reference to FIG. 28, after the hole 334is reamed the second and third wires 326, 328 may be removed. Inaddition, the template 100 may be removed by sliding the template 100off the first wire 324.

Referring now to FIGS. 29 and 30, an implant 200 may be selected andslid over the first wire or proximal k-wire 324. The wire 324 may beinserted into the hole 220 of the implant 200 and the implant 200 may beslid down the wire 324 until the plantar extension member 230 ispositioned into the reamed hole 334. Next, the size and position of theimplant 200 may be confirmed. In some embodiments, the implant 200 mayneed to be removed and replaced with a larger or smaller implant. Thedistance between the extension member 230 of each implant 200 and thehole 220 is constant. The constant distance allows the implant 200 to bereplaced with a larger or smaller implant 200 without having to removeor move the first wire 324 to achieve the proper position of theextension member 230 of the larger or smaller implant 200. In otherembodiments, if the extension member 230 does not seat properly in the4^(th)/5^(th) metatarsal joint, then the implant 200 may be removed andadditional reaming performed by reinserting the template 100 onto thefoot 300.

Once the desired size and position of the implant 200 is achieved, afourth wire 336, for example, a threaded olive wire, may be insertedinto the second fastener hole 224 to secure the position of the implant200, as shown in FIG. 31. In addition, the method may include insertinga drill guide 338 into the third fastener hole 228 of the third arm 226of the implant 200. Then, a drill bit 340 corresponding to the desiredfastener diameter may be inserted into the drill guide 338 and anopening (not shown) in the bone 306 may be drilled. The opening may bedrilled to a depth corresponding to the length of the fastener beinginserted. The depth may be determined using, for example, a depth gauge(not shown). After the opening (not shown) is drilled, the drill bit 340and drill guide 338 may be removed from the implant 200 and a thirdfastener 256 may be inserted through the third fastener hole 228 of theimplant 200 and into the fifth metatarsal 306, as shown in FIG. 32.Next, the wire 336 may be removed and the drill guide 338 may be coupledto the second fastener hole 224. An opening (not shown) in the fourthmetatarsal 304 may then be drilled as described above with reference tothe opening (not shown) drilled into the fifth metatarsal, which willnot be described again here for brevity sake. Once the opening (notshown) is drilled in the fourth metatarsal 304, the drill bit 340 anddrill guide 338 may be removed from the implant 200 and a secondfastener 254 may be inserted through the second fastener hole 224 of theimplant 200 and into the fourth metatarsal 304.

Referring now to FIG. 33, the first wire 324 may then be removed fromthe cuboid 308 and a k-wire guide 342 may be secured to the plantarextension member 230. The k-wire guide 342 may be inserted into andcoupled to the hole 232 of the extension member 230. A wire 344, forexample, a threaded k-wire, may be inserted through the guide 342 andinto the central aspect of the calcaneus 310, as shown in FIG. 33. Oncethe k-wire 344 is inserted into the calcaneus 310, the guide 342 may beremoved. A cannulated depth gauge 346 may then be inserted over the wire344 to measure the length of the wire 344, as shown in FIG. 34. Next,the method may include inserting a soft tissue protector 348 over thewire 344 and coupling the soft tissue protector 348 to the hole 232 ofthe extension member 230 of the implant 200, as shown in FIG. 35. Then,a drill bit 350 may be inserted over the wire 344 and through the softtissue protector 348 and hole 232 to drill a path between the fourth andfifth metatarsals 304, 306 and an opening in the cuboid 308 andcalcaneus 310. After the path between the fourth and fifth metatarsals304, 306 and the opening is drilled in the cuboid 308 and calcaneus 310,the drill bit 350, the soft tissue protector 348, and the wire 344 maybe removed from the foot 300.

A beam fastener 258 may then be inserted into the opening in the cuboid308 and calcaneus 310 through the hole 232 in the extension member 230of the implant 200, as shown in FIG. 36. The temporary fixators 312,314, 316 may be removed during insertion of the fastener 258 or afterinsertion of the fastener 258. For example, if the fastener 258 is acompression fastener, the temporary fixators 312, 314, 316 may beremoved from the joints 318, 320, 322 as the tip of the fastener 258advances past each joint and creates a compressive force as the fastener258 is inserted. After the fastener 258 is inserted, the length andposition of the fastener 258 may be confirmed using fluoroscopy.

Next, the fasteners 252 may be inserted through the first fastener holes218, as shown in FIG. 37. Although not shown, the fasteners 252 may beinserted as described in greater detail above with reference to FIGS. 31and 32. The method includes inserting a drill guide 338 into one firstfastener hole 218 of the first arm 216 of the implant 200. Then, thedrill bit 340 corresponding to the desired fastener diameter may beinserted into the drill guide 338 and a first opening (not shown) in thebone 308 may be drilled. The first opening may be drilled to a depthcorresponding to the length of the fastener being inserted. The depthmay be determined using, for example, a depth gauge (not shown). Afterthe first opening (not shown) is drilled, the drill bit 340 and drillguide 338 may be removed from the implant 200 and one first fastener 252may be inserted through the one first fastener hole 218 of the implant200 and into the cuboid 308, as shown in FIG. 37. A second firstfastener 252 may be inserted into a second first fastener hole 218 ofthe first arm 216 of the implant 200 as described above with referenceto the one first fastener 252 and which will not be described again herefor brevity sake. After the fasteners 252, 254, 256, 258 are eachinserted into the foot 300 through the implant 200, the method mayinclude performing incision closure or concomitant procedures.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprise” (andany form of comprise, such as “comprises” and “comprising”), “have” (andany form of have, such as “has”, and “having”), “include” (and any formof include, such as “includes” and “including”), and “contain” (and anyform of contain, such as “contains” and “containing”) are open-endedlinking verbs. As a result, a method or device that “comprises,” “has,”“includes,” or “contains” one or more steps or elements possesses thoseone or more steps or elements, but is not limited to possessing onlythose one or more steps or elements. Likewise, a step of a method or anelement of a device that “comprises,” “has,” “includes,” or “contains”one or more features possesses those one or more features, but is notlimited to possessing only those one or more features. Furthermore, adevice or structure that is configured in a certain way is configured inat least that way, but may also be configured in ways that are notlisted.

The disclosure has been described with reference to the preferredembodiments. It will be understood that the architectural andoperational embodiments described herein are exemplary of a plurality ofpossible arrangements to provide the same general features,characteristics, and general system operation. Modifications andalterations will occur to others upon a reading and understanding of thepreceding detailed description. It is intended that the disclosure beconstrued as including all such modifications and alterations.

Having thus described the preferred embodiments, the disclosure is nowclaimed to be:
 1. A fusion system, comprising: an alignment guide; animplant; and at least one fastener inserted through the implant.
 2. Thefusion system of claim 1, wherein the alignment guide comprises: a bodyportion; a first lobe positioned at a first end of the body portion; asecond lobe positioned at a second end of the body portion; and anextension member extending away from a first side of the body portion.3. The fusion system of claim 2, wherein the alignment guide furthercomprises: a reamer guide extending away from a top surface of theextension member adjacent to the body portion.
 4. The fusion system ofclaim 3, wherein the reamer guide comprises a reamer hole extending froma top surface of the reamer guide through a bottom surface of thealignment guide.
 5. The fusion system of claim 3, wherein the alignmentguide further comprises: a first hole extending through the first lobefrom a top surface to a bottom surface of the alignment guide; a secondhole extending through the second lobe from the top surface to thebottom surface of the alignment guide; and a third hole extendingthrough the extension member from the top surface to the bottom surfaceof the alignment guide.
 6. The fusion system of claim 3, wherein theextension member comprises: a first side extending from the body portionto a lateral side of the alignment guide at a first angle; and a secondside extending from the second lobe to the lateral side of the alignmentguide at a second angle, wherein the second angle is larger than thefirst angle.
 7. The fusion system of claim 3, wherein an end of thefirst lobe is rounded, wherein an end of the second lobe is rounded, andwherein an end of the extension member is rounded.
 8. The fusion systemof claim 6, wherein the extension member further comprises: a tabpositioned between the body portion and the lateral side of thealignment guide, wherein the tab extends away from the first side of theextension member.
 9. The fusion system of claim 1, wherein the implantcomprises: a body portion; a first arm extending away from the bodyportion in a first direction; a second arm extending away from the bodyportion in a second direction; and a third arm extending away from thebody portion laterally at a position between the first arm and thesecond arm.
 10. The fusion system of claim 9, wherein the firstdirection is positioned opposite the second direction, wherein the firstarm has a first length and the second arm has a second length, andwherein the first length is longer than the second length.
 11. Thefusion system of claim 9, wherein the implant further comprises: anextension member extending away from a bottom surface of the third arm.12. The fusion system of claim 11, wherein the extension membercomprises: a hole extending through the extension member in a directionsubstantially parallel to the first and second arms.
 13. The fusionsystem of claim 11, wherein an outer surface of the extension member isrounded.
 14. The fusion system of claim 11, wherein the extension memberis tapered from a bottom surface of the implant to a plantar end of theextension member.
 15. The fusion system of claim 14, wherein theextension member has a first taper in a dorsal-plantar direction and asecond taper in a medial-lateral direction.
 16. The fusion system ofclaim 11, wherein the implant further comprises: at least one firstfastener hole extending through the first arm from a top surface to abottom surface of the implant; at least one second fastener holeextending through the second arm from the top surface to the bottomsurface of the implant; at least one third fastener hole extendingthrough the third arm from the top surface to the bottom surface of theimplant; and a hole extending through the first arm from the top surfaceto the bottom surface of the implant.
 17. The fusion system of claim 16,wherein the fusion system further comprises: at least one guide wire,wherein the hole of the implant receives the at least one guide wire.18. The fusion system of claim 9, wherein the third arm is curvedtowards a proximal end of the implant as the third arm extends away fromthe body portion.
 19. A method for using a fusion system, comprising:preparing at least one joint; inserting temporary fixation k-wiresacross the at least one joint; obtaining an alignment guide; positioningthe alignment guide on a foot over the at least one joint; reaming arecess into the at least one joint through an opening in the alignmentguide; positioning an implant on the foot, wherein the implantcomprises: a body portion; a first arm extending away from the bodyportion in a first direction; a second arm extending away from the bodyportion in a second direction; a third arm extending away from the bodyportion laterally at a position between the first arm and the secondarm; and an extension member extending away from a bottom surface of thethird arm, wherein the extension member is inserted into the recess inthe at least one joint; fixing the implant to the foot; removing thetemporary fixation k-wires; and closing an incision.
 20. The method ofclaim 19, wherein fixing the implant to the foot comprises: inserting atleast one first bone fastener through the first arm; inserting at leastone second bone fastener through the second arm; inserting at least onethird bone fastener through the third arm; and inserting a beam fastenerthrough the extension member and into a cuboid and calcaneus of thefoot.